Remote Local Study Director – Oncology Trials Lead

Parexel; Dover (DE); Remote; USD 110,000 - 150,000; Full time

Job summary

Parexel is seeking a Local Study Associate Director (LSAD) in a remote US role. The LSAD leads Local Study Teams to deliver study components in compliance with ICH-GCP and local regulations, including site selection, qualification, monitoring, and documentation management.

Responsibilities include coordinating regulatory submissions, risk management, budgeting, and vendor management while maintaining strong relationships with investigators, sites, and global stakeholders.

Qualifications

• Must demonstrate ability to lead cross-functional teams in clinical studies.
• Proven project management and organizational skills are required.
• Strong English language proficiency; local language fluency may be required.
• Knowledge of ICH-GCP and local regulatory requirements is essential.

Responsibilities

• Lead Local Study Teams to deliver study components on time and within budget.
• Coordinate site selection, qualification visits, and monitoring activities.
• Oversee document management, regulatory submissions, and archiving.
• Ensure country-level study activities comply with SOPs and regulations.
• Collaborate with global stakeholders and data delivery teams.

Skills

Leadership

Project management

Team coordination

Cross-functional collaboration

Communication skills

English proficiency

Regulatory knowledge

Risk management

Site monitoring

Education

Bachelor’s degree in life sciences or related

Job description

Parexel is seeking a Local Study Associate Director (LSAD) in a remote US role. The LSAD leads Local Study Teams to deliver study components in compliance with ICH-GCP and local regulations, including site selection, qualification, monitoring, and documentation management.

Responsibilities include coordinating regulatory submissions, risk management, budgeting, and vendor management while maintaining strong relationships with investigators, sites, and global stakeholders.